On September 17, Russian drug manufacturer Generium announced that its dornase alfa biosimilar, Tigerase®, has been approved and launched in Russia. Tigerase® references Genentech’s Pulmozyme® and is the first dornase alfa biosimilar to be approved in any market worldwide. Dornase alfa is used in combination with other therapies to improve…
On September 25, 2019, Shanghai Henlius Biotech, Inc. (2696. HK) completed its US$410 million initial public offering and listing on the main board of the Stock Exchange of Hong Kong, marking the largest biotech IPO in Hong Kong this year. According to Henlius’ Global Offering, China International Capital Corp., Bank…
Over the summer, Goodwin and Bristows sat down with senior in-house counsel at the forefront of the biosimilars industry to discuss the pace of biosimilars market entry in the EU and U.S., why it has been so different in those two markets, and what the future holds. In the first…
As we previously reported, Amgen filed a complaint against Adello Biologics and Amneal alleging infringement of several patents, including certain claims of U.S. Patent No. 8,952,138, directed to a protein refolding process. In their answer, Adello sought a declaratory judgment that certain claims of the ’138 patent were not infringed…
Below are some highlights of recent biosimilar development news from this week: On September 20, Mochida announced that it had obtained marketing approval in Japan for RGB-10, a biosimilar of FORTEO (teraparitide) that Mochida developed in Japan based on a comprehensive license and collaboration agreement with Gedeon Richter Plc. Mochida…
On September 17, 2019, the U.S. District Court for the Western District of Pennsylvania endorsed the parties’ stipulation and proposed order of non-infringement of U.S. Patent No. 9,643,997 in favor of Mylan, thereby resolving all pending disputes between the parties in Amgen v. Mylan, Civil Action No. 17-cv-1235, the BPCIA…
In February of this year, Amgen filed three petitions for inter partes review (IPR) of Alexion Pharmaceuticals’ U.S. Patent Nos. 9,725,504 (IPR2019-00739), 9,718,880 (IPR2019-00740), and 9,732,149 (IPR2019-00741). The claims of the challenged patents are directed to the monoclonal antibody eculizumab, which is the active ingredient in Alexion’s SOLIRIS, or methods…
On September 5, JHL Biotech announced that it has reached a settlement agreement with Genentech to resolve the parties’ lawsuit regarding JHL’s alleged misappropriation of trade secrets relating to Genentech’s Rituxan® (rituximab), Herceptin® (trastuzumab), Avastin® (bevacizumab), and Pulmozyme® (dornase alfa) products. As we previously reported, in October 2018, Genentech filed…
In August, the American College of Rheumatology released updated guidelines for the treatment of ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpA), the two types of axial spondyloarthritis. The new recommendations suggest that patients use TNF inhibitors (Humira, Cimzia and Enbrel) as first-line therapy, followed by IL-17 inhibitors (Cosentyx and Taltz)…
This past May, in the Amgen v. Sandoz BPCIA litigation concerning Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and proposed pegfilgrastim biosimilar, a Federal Circuit panel affirmed the district court’s judgment of non-infringement in favor of Sandoz. The panel found that Amgen could not prevail on its infringement claims under the doctrine of…